Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K201219
Biocore9 Femoral Head Resurfacing Component · Biocore9, LLC · decided 2021-01-19 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Biocore9 Femoral Resurfacing Component | Femoral Resurfacing Component - 39.5 mm | Biocore9, LLC | KXA | 00810068850383 |
| Biocore9 Femoral Resurfacing Component | Femoral Resurfacing Component - 41 mm | Biocore9, LLC | KXA | 00810068850390 |
| Biocore9 Femoral Resurfacing Component | Femoral Resurfacing Component - 51 mm | Biocore9, LLC | KXA | 00810068850451 |
| Biocore9 Femoral Resurfacing Component | Femoral Resurfacing Component - 52.5 mm | Biocore9, LLC | KXA | 00810068850468 |
| Biocore9 Femoral Resurfacing Component | Femoral Resurfacing Component - 44 mm | Biocore9, LLC | KXA | 00810068850413 |
| Biocore9 Femoral Resurfacing Component | Femoral Resurfacing Component - 42.5 mm | Biocore9, LLC | KXA | 00810068850406 |
| Biocore9 Femoral Resurfacing Component | Femoral Resurfacing Component - 45.5 mm | Biocore9, LLC | KXA | 00810068850420 |
| Biocore9 Femoral Resurfacing Component | Femoral Resurfacing Component - 47 mm | Biocore9, LLC | KXA | 00810068850437 |
| Biocore9 Femoral Resurfacing Component | Femoral Resurfacing Component - 49 mm | Biocore9, LLC | KXA | 00810068850444 |